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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry - rapid tests & point of care
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Fertility / pregnancy rt & poc
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Hcg - rt & poc
Hcg - rt & poc
W0102160302
523 devices
Dr. Max Digital Pregnancy Rapid Test
Guangzhou Decheng Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
One-Step HCG Pregnancy Test
Shanghai Chemtron Biotech Co., Ltd.
·
,
China
IVD for self-testing
FDA 510(k)
×2
K132085
Active
Cleared 12 Nov 2013
CE/IVDD
hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
hCG Pregnancy Rapid Test Dipstick (Urine)
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
RapidFor™ hCG + LH Combo Rapid Test Kit
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
Fertilitätsmonitor Advanced
Spd Swiss Precision Diagnostics GmbH
·
,
Switzerland
IVD for self-testing
CE/IVDD
FSH/LH/PRL Rapid Quantitative Test (Fluorescence Immunoassay)
Xiamen BioRay Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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